Coronary ArteriosclerosisNCT02919124
Epicardial Echocardiography of Coronary Anastomoses Using the Echoclip Device
A study testing Echoclip in people with Coronary Arteriosclerosis, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
The aim of this study is to evaluate whether use of the echoclip device (an ultrasound transducer positioning device which can stabilize the involved part of the myocardium on the beating heart) facilitates imaging of coronary bypass anastomoses during coronary bypass surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arteriosclerosis
- What is being tested?
- Echoclip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2016to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective on-pump coronary artery bypass surgery
- Surgery planned to be performed by specialist in cardiac surgery.
- Logistic euroSCORE II <6%.
- Must be able to read and understand the Danish
- Written informed acceptance to participate
Who cannot join
- Planned off-pump surgery.
- Peroperativ conversion to off-pump surgery.
- Logistic EuroSCORE II ≥ 6.
- The patient do not understand written or spoken Danish.
- Surgery within 24 hours after admittance to hospital
- Patients in whom the surgeon wants to end the surgery in a hurry due to e.g. hemodynamic problems or peroperative complications.
Show all 9Show fewer
- The surgeon is not a specialist in cardiac surgery, e.g. surgeon in training.
- Pregnant or brest feeding patient.
- No written acceptance to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: During Coronary Artery Bypass Surgery. A Feasibility Study.
The aim of this study is to evaluate whether use of the echoclip device (an ultrasound transducer positioning device which can stabilize the involved part of the myocardium on the beating heart) facilitates imaging of coronary bypass anastomoses during coronary bypass surgery. A total of 100 low risk patients undergoing elective on-pump coronary bypass surgery will be included in the study in order to evaluate if the surgeons can visualize the coronary anastomoses before closure of the sternum. Ultrasonograpic pictures will be analyzed directly peroperatively and electronically post-operatively in order to evaluate if selected areas of the anastomoses can be visualized. Use of the echoclip devise will be considered a success if at least 80% of the anastomoses can be visualized.
Read the detailed description
The technical quality of coronary artery bypass anastomoses during coronary artery bypass grafting is often evaluated by measuring flow rate in grafts using transit time flowmetry. Unfortunately, flow rate and flow waveform are poor indicators of the anatomy of anastomoses. A better way to evaluate the anatomy of an anastomosis is 3-dimensional imaging. Three problems must be overcome in performing epicardial echocardiography on the beating heart:
- The transducer must be kept in a steady position relative to the anastomosis for 5 to 10 cardiac cycles to minimize frame-rate variability.
- Ultrasound gel must be kept in contact with the transducer and the region studied.
- The transducer must not cause any deformation of the vessels.
The investigators designed an ultrasound transducer positioning device, the Echoclip device (Aalborg Hospital, Aalborg, Denmark), which can stabilize the involved part of the myocardium on the beating heart, keep the gel at place, and position the ultrasound transducer correctly for imaging. The present study is a feasibility study with the aim to evaluate if the echoclip device facilitates imaging of coronary bypass anastomoses during coronary artery bypass surgery in humans to the same degree as was shown in animal studies. Ultrasonography will be used for visualizing all coronary anastomoses during 100 elective low-risk (logistic II EuroSCORE <6) on-pump coronary artery bypass procedures. It will be registered if the heel, the central portion and the toe of the anastomosis can be visualized in end-to-side and side-to-side anastomoses.Use of the echoclip devise will be considered a success if at least 80% of all parts of the anastomoses can be visualized either directly or by electronic reading using a special developed algorithm that may identify the inner border of the anastomoses.
- Conditions
- Coronary Arteriosclerosis
- Being tested
- Echoclip
- Keywords
- Coronary artery bypass grafting, Anastomosis, Ultrasonography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchoclipDevice
An ultrasound transducer positioning device, the Echoclip device (Aalborg Hospital, Aalborg,Denmark), which can stabilize the involved part of the myocardium on the beating heart, keep the gel at place, and position the ultrasound transducer correctly for imaging will be used for visualising the coronary bypass anastomoses during surgery
| Study group | Role | What they receive |
|---|---|---|
| Echoclip device | Experimental | Ultrasonography using the echoclip device Receives: Device: Echoclip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of periferal coronary artery bypass anastomotic structures
Ultrasonographic images of periferal coronary artery bypass anastomoses will be studied in order to evaluate if the area of anastomotic structures from various locations of the anastomoses (heel, central portion and the to toe) can be visualized directly on the screen using the echoclip device.
Measured: Peroperative
Secondary outcomes (1)
Automatic quality control of periferal coronary artery bypass anastomotic structures
To quantify the anastomotic quality from epicardial utrasound images obtained peroperative, the area of anastomotic structures from various locations of the anastomoses (heel, central portion and the to toe) will be meassured using an automatic anastomosis segmentation algorithm to extract the area of the anastomotic structures. The ultrasound images obtained peroperative will be analyzed in the Laboratory when 50 patients and 100 patients have been included in the study, respectively.
Measured: Peroperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary ArteriosclerosisStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University, Medistim ASA
- Responsible party
- Principal investigator, Jan Jesper Andreasen, Professor, MD, PhD, Aalborg University Hospital
- Investigators
- Jan J Andreasen, MD, PhD, Principal investigator, Aalborg University Hospital and Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919124
- Sponsor's protocol ID
- 0089Y
- Status last verified
- Jan 2020
- First submitted
- 25 Sep 2016
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Individual participant data are available for Monitor
Publications
Staalsen NH, Kjaergaard B, Andreasen JJ. A new technique facilitating intraoperative, high-frequency echocardiography of coronary bypass graft anastomoses. J Thorac Cardiovasc Surg. 2011 Jan;141(1):295-6. doi: 10.1016/j.jtcvs.2009.11.074. No abstract available.
PubMed 21168035Jorgensen AS, Andersen MS, Ostergaard LR, Schmidt SE, Nohr D, Andreasen JJ. A laboratory feasibility study using a computer algorithm for anastomosis segmentation of epicardial ultrasonography images from distal coronary artery bypass anastomoses. J Cardiothorac Surg. 2025 Jan 6;20(1):34. doi: 10.1186/s13019-024-03187-8.
PubMed 39762954Andreasen JJ, Nohr D, Jorgensen AS, Haahr PE. Peroperative epicardial ultrasonography of distal coronary artery bypass graft anastomoses using a stabilizing device. A feasibility study. J Cardiothorac Surg. 2020 Jan 8;15(1):3. doi: 10.1186/s13019-020-1057-x.
PubMed 31915030Andreasen JJ, Nohr D, Jorgensen AS. A case report on epicardial ultrasonography of coronary anastomoses using a stabilizing device without the use of ultrasound gel. J Cardiothorac Surg. 2019 Mar 13;14(1):59. doi: 10.1186/s13019-019-0882-2.
PubMed 30866994
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- During Coronary Artery Bypass Surgery. A Feasibility Study.
- ClinicalTrials.gov ID
- NCT02919124
- Acronym / sponsor ID
- 0089Y
- Conditions
- Coronary Arteriosclerosis
- Keywords
- Coronary artery bypass grafting, Anastomosis, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University, Medistim ASA
- Study start
- Sep 2016
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate whether use of the echoclip device (an ultrasound transducer positioning device which can stabilize the involved part of the myocardium on the beating heart) facilitates imaging of coronary bypass anastomoses during coronary bypass surgery. A total of 100 low risk patients undergoing elective on-pump coronary bypass surgery will be included in the study in order to evaluate if the surgeons can visualize the coronary anastomoses before closure of the sternum. Ultrasonograpic pictures will be analyzed directly peroperatively and electronically post-operatively in order to evaluate if selected areas of the anastomoses can be visualized. Use of the echoclip devise will be considered a success if at least 80% of the anastomoses can be visualized.
Detailed description
The technical quality of coronary artery bypass anastomoses during coronary artery bypass grafting is often evaluated by measuring flow rate in grafts using transit time flowmetry. Unfortunately, flow rate and flow waveform are poor indicators of the anatomy of anastomoses. A better way to evaluate the anatomy of an anastomosis is 3-dimensional imaging. Three problems must be overcome in performing epicardial echocardiography on the beating heart:
- The transducer must be kept in a steady position relative to the anastomosis for 5 to 10 cardiac cycles to minimize frame-rate variability.
- Ultrasound gel must be kept in contact with the transducer and the region studied.
- The transducer must not cause any deformation of the vessels.
The investigators designed an ultrasound transducer positioning device, the Echoclip device (Aalborg Hospital, Aalborg, Denmark), which can stabilize the involved part of the myocardium on the beating heart, keep the gel at place, and position the ultrasound transducer correctly for imaging. The present study is a feasibility study with the aim to evaluate if the echoclip device facilitates imaging of coronary bypass anastomoses during coronary artery bypass surgery in humans to the same degree as was shown in animal studies. Ultrasonography will be used for visualizing all coronary anastomoses during 100 elective low-risk (logistic II EuroSCORE <6) on-pump coronary artery bypass procedures. It will be registered if the heel, the central portion and the toe of the anastomosis can be visualized in end-to-side and side-to-side anastomoses.Use of the echoclip devise will be considered a success if at least 80% of all parts of the anastomoses can be visualized either directly or by electronic reading using a special developed algorithm that may identify the inner border of the anastomoses.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Echoclip device | Experimental | Device: EchoclipUltrasonography using the echoclip device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Elective on-pump coronary artery bypass surgery
- Surgery planned to be performed by specialist in cardiac surgery.
- Logistic euroSCORE II <6%.
- Must be able to read and understand the Danish
- Written informed acceptance to participate
Key exclusion criteria (9 listed)
- Planned off-pump surgery.
- Peroperativ conversion to off-pump surgery.
- Logistic EuroSCORE II ≥ 6.
- The patient do not understand written or spoken Danish.
- Surgery within 24 hours after admittance to hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchoclipAn ultrasound transducer positioning device, the Echoclip device (Aalborg Hospital, Aalborg,Denmark), which can stabilize the involved part of the myocardium on the beating heart, keep the gel at place, and position the ultrasound transducer correctly for imaging will be used for visualising the coronary bypass anastomoses during surgery | Device | Echoclip device |
Primary outcome
Quality of periferal coronary artery bypass anastomotic structures
Time frame: Peroperative
Ultrasonographic images of periferal coronary artery bypass anastomoses will be studied in order to evaluate if the area of anastomotic structures from various locations of the anastomoses (heel, central portion and the to toe) can be visualized directly on the screen using the echoclip device.
1 secondary outcome
Automatic quality control of periferal coronary artery bypass anastomotic structures
Time frame: Peroperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Results publication: PubMed 21168035Staalsen NH, Kjaergaard B, Andreasen JJ. A new technique facilitating intraoperative, high-frequency echocardiography of coronary bypass graft anastomoses. J Thorac Cardiovasc Surg. 2011 Jan;141(1):295-6. doi: 10.1016/j.jtcvs.2009.11.074. No abstract available.
- Derived from this study: PubMed 39762954Jorgensen AS, Andersen MS, Ostergaard LR, Schmidt SE, Nohr D, Andreasen JJ. A laboratory feasibility study using a computer algorithm for anastomosis segmentation of epicardial ultrasonography images from distal coronary artery bypass anastomoses. J Cardiothorac Surg. 2025 Jan 6;20(1):34. doi: 10.1186/s13019-024-03187-8.
- Derived from this study: PubMed 31915030Andreasen JJ, Nohr D, Jorgensen AS, Haahr PE. Peroperative epicardial ultrasonography of distal coronary artery bypass graft anastomoses using a stabilizing device. A feasibility study. J Cardiothorac Surg. 2020 Jan 8;15(1):3. doi: 10.1186/s13019-020-1057-x.
- Derived from this study: PubMed 30866994Andreasen JJ, Nohr D, Jorgensen AS. A case report on epicardial ultrasonography of coronary anastomoses using a stabilizing device without the use of ultrasound gel. J Cardiothorac Surg. 2019 Mar 13;14(1):59. doi: 10.1186/s13019-019-0882-2.
- Individual participant dataSharing planned: Yes. Individual participant data are available for Monitor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan J Andreasen, MD, PhD principal investigator
Aalborg University Hospital and Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echoclip in people with Coronary Arteriosclerosis, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of periferal coronary artery bypass anastomotic structures (time frame: Peroperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02919124, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.